FDA 510(k)

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

Numéro K : K210615 · 2022-05-13

DemandeurThompson Surgical Instruments, Inc.

Date de décision2022-05-13

Code produitGZT

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210615. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Thompson Surgical Instruments, Inc.. The 510(k) number is K210615.

When did Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) receive FDA 510(k) clearance?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210615.

Who is the listed applicant for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA 510(k) record lists Thompson Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is GZT.

Essais cliniques associés

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Dispositifs connexes (Code : GZT)

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Source officielle

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